Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125840
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2005-07-29
Brief Title:
Clofarabine in Adult Patients With Advanced Solid Tumors
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clofarabine injection is approved by the Food and Drug Administration FDA for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia ALL who have had at least 2 prior treatment regimens
This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available The purpose of this study is to find the answers to the following research questions
1 What is the largest dose of clofarabine that can be safely administered as an IV infusion over at least 2 hours once a week for 3 weeks days 1 8 and 15 followed by 1 week of rest and repeated every 28 days
2 What are the side effects of clofarabine when given on this schedule
3 How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug Once the MTDRP2D is established patients will be enrolled at the MTDRP2D regardless of the PK data with cardiac assessments done every other cycle
4 Will clofarabine help treat a specific cancer
This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available The purpose of this study is to find the answers to the following research questions
1 What is the largest dose of clofarabine that can be safely administered as an IV infusion over at least 2 hours once a week for 3 weeks days 1 8 and 15 followed by 1 week of rest and repeated every 28 days
2 What are the side effects of clofarabine when given on this schedule
3 How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug Once the MTDRP2D is established patients will be enrolled at the MTDRP2D regardless of the PK data with cardiac assessments done every other cycle
4 Will clofarabine help treat a specific cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None